An Assessment of Safety and Efficacy of the abdominal subcutaneous fat reduction effects of ALPHA : Prospective, Multicenter, Single arm and Academic clinical trial
The purpose of this clinical trial is to assess the efficacy and safety of the ALPHA using Cryolipolysis technology for the abdominal subcutaneous fat reduction.
A. Duration of Clinical Study : approximately 17 weeks (119 days)
B. No. of Hospital Visits : 5 ~ 6 / No. of Treatments : 2
(※ 5 Hospital Visits : If screening and first procedure are conducted on the same day.)
C. The subject will undergo vital signs, physical exams, and other assessments on visit
(※ Subjects should expect that each visit including treatment will take approximately 4 hours ; 3 hours per visit that exclude treatments.)
A. Healthy subject(Male or Female) at age range 19 – 65
B. Subject who has clearly visible fat on the abdomen
C. Subject agrees to maintain weight by not making any changes in their lifestyle such as diet or exercise routine during the course of the study.
D. Subject who understands and follows the instructions and is able to participate in the entire duration of this clinical trial
For subjects who formally consent to participate in this clinical trial, which includes undergoing evaluation and treatments, a series of surveys and tests will be conducted to determine your eligibility as a study subject.
A. Hypersensitivity due to topical application of a local anesthetic (when the subject only uses Emla Cream)
B. During & Post Treatment: pulling, severe coldness, tingling, prickling, blanching, erythema (redness), bruising, edema(swelling), numbness, nausea
C. The possibility of unexpected adverse events following the participation of clinical trial
|CLASSYS (Inc.)||070-4742-7830||240, Teheran-ro, Gangnam-gu, Seoul, Rep. of Korea,|
Chung-Ang University Hospital
Han-Yang University Hospital
Joo Yeon Ko
102, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea